BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BATTERY CHARGE II

    MDR report key: 4791686 · Received May 22, 2015

    Report

    Report Number
    3009450871-2015-11630
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    MOQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. (B)(4) EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE DID NOT FUNCTION AND BAY ONE DISPLAYED A RED WARNING LIGHT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO USAGE WEAR OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SERVICE AND REPAIR PRE-TESTING, IT WAS OBSERVED THAT BAY ONE ON THE UNIVERSAL BATTERY CHARGER DEVICE WAS DISPLAYING THE RED WARNING LIGHT EMITTING DIODE (LED) LIGHTS. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336521 UNIVERSAL BATTERY CHARGE II BATTERY, REPLACEMENT, RECHARGEABLE MOQ DEPUY SYNTHES POWER TOOLS 004126

    Patients

    Seq Age Sex Outcome Treatment
    1